CN111982894A

CN111982894A - Portable test paper detection device

Info

Publication number: CN111982894A
Application number: CN202010647683.5A
Authority: CN
Inventors: 刘志军; 李小静; 高红旗; 潘炜华; 方文捷; 张克明; 邓宇晨; 刘伊诺; 陈娟; 郦小平; 潘亦斌
Original assignee: Baolong Pharmaceutical Co ltd; Moon Guangzhou Biotech Co ltd; Affiliated Hospital Of Hebei University Of Engineering; Shanghai Changzheng Hospital
Current assignee: Baolong Pharmaceutical Co ltd; Moon Guangzhou Biotech Co ltd; Affiliated Hospital Of Hebei University Of Engineering; Shanghai Changzheng Hospital
Priority date: 2020-07-07
Filing date: 2020-07-07
Publication date: 2020-11-24

Abstract

The invention provides a portable test paper detection device which comprises a main body and a sample tube, wherein a second puncturing mechanism is arranged on the wall of the main body, one end of the second puncturing mechanism is arranged in the main body, the other end of the second puncturing mechanism is arranged outside the main body, the second puncturing mechanism can move from a first position to a second position, when the detection device is not used, the second puncturing mechanism is located at the first position, and when the second puncturing mechanism is moved to the second position, the second puncturing mechanism punctures a sealing layer. By adopting the technical scheme, after the detection of the chromatographic test paper is finished, the second puncturing mechanism can move to the second position to puncture the sealing layer, so that the liquid in the liquid storage tank reacts with the sample solution on the chromatographic test paper and in the sample tube, and the residual nucleic acid in the portable test paper detection device is completely removed. Therefore, even if the sample tube is accidentally dropped in the subsequent process or the portable test paper detection device is damaged, the interior of the portable test paper detection device is exposed, and no pollution is caused.

Description

Portable test paper detection device

Technical Field

The invention relates to the field of detection, in particular to a portable test paper detection device.

Background

Nucleic acid diagnostics is one of the most active segments of the future IVD (in vitro diagnostics) industry. The increasing of the prevention and treatment of infectious diseases, the popularization of blood screening nucleic acid detection and the development of individualized medical treatment in China are the main motivations for the development of nucleic acid diagnosis in China. Under the promotion of the factors, the future speed increase of domestic nucleic acid diagnosis is 25-30%, and obviously exceeds the average speed increase of domestic IVD industry. On one hand, the nucleic acid diagnosis benefits large medical centers and realizes early, rapid, specific and high-throughput detection of pathogens, genetic diseases and the like.

POCT (Point-of-care testing), which is a new subdivision industry of In Vitro Diagnosis (IVD), is a new method for analyzing samples immediately on a sampling site, saving complex processing procedures of samples during laboratory testing and quickly obtaining testing results. The main criteria for POCT are that no fixed detection site is required, that the reagents and instruments are portable and that they can be operated in a timely manner. POCT plays the role of a laboratory, does not need traditional hospital laboratory equipment, and can serve patients in all directions within 24 hours without the limitation of time and place.

However, these nucleic acid amplification methods have a problem that the amplification products are easily cross-contaminated, and false positive signals generated by product contamination may cause erroneous interpretation of the detection results. Cross-contamination between samples is often seen during target nucleic acid amplification procedures, and contamination may result from known or unknown positive species introduced during negative sample processing, which causes false positive reactions through air contamination or aerosols.

In the prior art, a series of methods have been developed to prevent cross contamination of amplification products, and for example, reference 1(CN105199940A) discloses a portable anti-contamination gene detection method and apparatus, by which a nucleic acid amplification tube containing an amplification product can be sealed in an apparatus and then the nucleic acid amplification tube is punctured to perform detection. Prevent the pollution of nucleic acid amplification products and avoid false positive. However, in this apparatus, since the nucleic acid amplification tube is sealed after being placed in the apparatus, the puncturing operation is difficult, and the amplification product after the completion of the test remains in the apparatus, and if the nucleic acid amplification tube is broken, the amplification product may also diffuse into the air, causing a false positive reaction.

Further, while reference 2(CN203241416U) discloses a closed type chromatography strip plastic cartridge, and reference 3(CN205574438U) discloses a sealed tube assembly including a tube breaking mechanism, these detection devices are convenient to operate, but the amplification product remains in the device after detection, which may cause contamination.

Therefore, it is an urgent problem in the art to provide a nucleic acid detecting apparatus with less contamination possibility before and after detection.

Disclosure of Invention

The invention aims to solve the problems that a closed detection device in the prior art is inconvenient to operate and has pollution possibility after detection. In order to solve the problems, the invention discloses a portable test paper detection device which is convenient to operate and can effectively prevent amplification products from diffusing into the air to cause false positive reaction.

In order to solve the problems, the invention discloses a portable test paper detection device, which comprises a main body and a sample tube,

a containing cavity is arranged in the main body, a liquid storage tank, a sealing layer, chromatography test paper and a first puncture mechanism are sequentially arranged in the containing cavity from bottom to top, the upper surface of the liquid storage tank is sealed by the sealing layer, the first puncture mechanism is fixedly connected in the main body, a fluid channel is arranged on the first puncture mechanism,

the wall of the main body is further provided with a second puncturing mechanism, one end of the second puncturing mechanism is arranged in the main body, the other end of the second puncturing mechanism is arranged outside the main body, the second puncturing mechanism can move from the first position to the second position, when the detection device is not used, the second puncturing mechanism is located at the first position, and when the second puncturing mechanism is moved to the second position, the second puncturing mechanism punctures the sealing layer.

By adopting the technical scheme, after the detection of the chromatographic test paper is finished, the second puncturing mechanism can move to the second position to puncture the sealing layer, so that the liquid in the liquid storage tank reacts with the sample solution on the chromatographic test paper and in the sample tube, and the residual nucleic acid in the portable test paper detection device is completely removed. Therefore, even if the sample tube is accidentally dropped in the subsequent process or the portable test paper detection device is damaged, the interior of the portable test paper detection device is exposed, and no pollution is caused.

According to another embodiment of the invention, the second lancing mechanism is connected to the body by a threaded connection and the second lancing mechanism can be moved from the first position to the second position by rotating the second lancing mechanism.

According to another embodiment of the present invention, a barrier is disposed between the sealing layer and the second puncturing mechanism, the barrier is movable from a third position to a fourth position, the barrier blocks the second puncturing mechanism from moving downward when the barrier is at the third position, and the puncturing mechanism punctures the sealing layer as the sample tube is rotated in when the barrier is moved to the fourth position.

According to another embodiment of the present invention, the sample solution adding region comprises a cylindrical first channel, and the insertion end of the first channel is provided with a sealing ring made of elastomer, or the side wall of the sample tube is externally provided with a sealing ring made of elastomer.

According to another embodiment of the present invention, the detection result observation area is made of a transparent material.

Drawings

The invention will be described in further detail with reference to the following figures and detailed description:

FIG. 1 is a perspective view of a portable test strip detection device according to the present invention;

FIG. 2 is a cross-sectional view of the portable test strip testing device provided by the present invention;

FIG. 3 is an exploded view of the portable test strip detection device provided by the present invention;

FIG. 4 is a cross-sectional view of a sample tube provided by the present invention;

FIG. 5 is a schematic structural diagram of a sample tube provided in the present invention.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will become apparent to those skilled in the art from the present disclosure. While the invention will be described in conjunction with the preferred embodiments, it is not intended that features of the invention be limited to these embodiments. On the contrary, the invention is described in connection with the embodiments for the purpose of covering alternatives or modifications that may be extended based on the claims of the present invention. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be practiced without these particulars. Moreover, some of the specific details have been left out of the description in order to avoid obscuring or obscuring the focus of the present invention. It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.

In the description of the present embodiment, it should be noted that the terms "upper", "lower", "inner", "bottom", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships that are conventionally placed when the products of the present invention are used, and are only used for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the devices or elements indicated must have specific orientations, be configured in specific orientations, and operate, and thus, should not be construed as limiting the present invention.

The terms "first," "second," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

In the description of the present embodiment, it should be further noted that, unless explicitly stated or limited otherwise, the terms "disposed," "connected," and "connected" are to be interpreted broadly, e.g., as a fixed connection, a detachable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present embodiment can be understood in specific cases by those of ordinary skill in the art.

In order to make the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Referring to fig. 1-5, the present invention discloses a portable test paper detection device, which comprises a main body 200 and a sample tube 100, wherein a bottom wall 120 of the sample tube 100 is provided with a cut mark, a containing cavity 210 is arranged in the main body 200, a liquid storage tank 220, a sealing layer 221, a chromatography test paper 240 and a first puncturing mechanism 250 are sequentially arranged in the containing cavity 210 from bottom to top, the upper surface of the liquid storage tank 220 is sealed by the sealing layer 221, the first puncturing mechanism 250 is fixedly connected in the main body 200, the first puncturing mechanism 250 is provided with a fluid channel 251,

the wall of the main body 200 is further provided with a second piercing means 29, one end of the second piercing means 29 being arranged inside the main body 200 and the other end being arranged outside the main body 200, the second piercing means 29 being movable from a first position, in which the second piercing means 29 is located, when the detection device is not in use, to a second position, in which the second piercing means 29 pierces the sealing layer 221,

the upper surface of the main body 200 is provided with a sample solution adding region 260 and a detection result observation region 270, the sample solution adding region 260 is configured for inserting the sample tube 100, and after the sample tube 100 is inserted into the sample solution adding region 260, the accommodating chamber 210 is sealed, the first puncturing mechanism 250 punctures the bottom wall 120 of the sample tube 100, and the sample solution flows into the accommodating chamber 210 from the fluid channel 251.

That is, the portable test paper detection device mainly comprises a main body 200 and a sample tube 100, wherein a containing cavity 210 is arranged in the main body 200, a liquid storage tank 220, a sealing layer 221, a chromatography test paper 240 and a first puncture mechanism 250 are sequentially arranged in the containing cavity 210 from bottom to top, and the upper surface of the liquid storage tank 220 is sealed by the sealing layer 221. When the detection device is not used, the sealing layer 221 can seal the liquid storage tank 220, so as to prevent the liquid in the liquid storage tank 220 from reacting with the sample solution on the chromatography test paper 240 and in the sample tube 100, and ensure the usability of the detection device, and at this time, the second puncturing mechanism 29 is located at the first position. After the detection of the chromatographic test paper 240 is completed, the second puncturing mechanism 29 can move to the second position to puncture the sealing layer 221, so that the liquid in the liquid storage tank 220 reacts with the sample solution on the chromatographic test paper 240 and in the sample tube 100, and the residual nucleic acid in the portable test paper detection device is completely removed. Therefore, even if the sample tube 100 is accidentally dropped in the subsequent process or the portable test paper detection device is damaged, the internal exposure is caused, and no pollution is caused.

In this embodiment, the liquid storage tank 220 may store therein a nucleic acid-disrupting reagent, such as a sodium hypochlorite solution or a solution of a commercial DNA detergent. In other embodiments, other solutions may be stored in the liquid storage tank as long as the solutions can react with the sample solution to prevent the sample solution from being contaminated.

Further, the upper surface of the main body 200 is provided with a sample solution adding region 260 and a detection result observing region 270, the sample solution adding region 260 is configured for inserting the sample tube 100, and after the sample tube 100 is inserted into the sample solution adding region, the accommodating chamber 210 is sealed, the first puncturing mechanism 250 punctures the sample tube 100, and the sample solution flows into the accommodating chamber 210 from the fluid channel 251 to react with the chromatography test paper 240 in the accommodating chamber 210.

For example, the shape of the sample solution adding region 260 may be configured to match the sample tube 100, and after the sample tube 100 is inserted into the sample solution adding region 260, the surfaces of the two are attached to each other, so as to seal the accommodating chamber 210.

During the detection process, the accommodating cavity 210 is always sealed, so that the amplification product is prevented from leaking outwards. After the test result is recorded, the sealing layer 221 can be punctured by the second puncturing mechanism 29, and the chromatographic test paper 240 can react with the nucleic acid-disrupting reagent, so that the nucleic acid remaining in the portable test paper testing device can be completely removed. Therefore, even if the sample tube 100 is accidentally dropped in the subsequent process or the portable test paper detection device is damaged, the internal exposure is caused, and no pollution is caused.

It should be noted that the specific structure of the second puncturing mechanism and the connection manner with the main body are not limited in the present invention, and may be reasonably set according to the actual situation, as long as the second puncturing mechanism can puncture the sealing layer after the detection of the chromatographic test paper is completed.

According to another embodiment of the present invention, referring to fig. 1-5, the second lancing mechanism 29 is disposed on the upper wall of the main body 200 with one end extending into the main body 200 and the other end extending outside the main body 200 and threadably connected to the main body 200, and the second lancing mechanism 29 can be moved from the first position to the second position by rotating the second lancing mechanism 29. The upper wall of the main body 200 is provided with a threaded passage (not shown) for mounting the second piercing means 29, the threaded passage is arranged along a direction perpendicular (as shown by X in fig. 2) to the upper surface of the main body 200, an internal thread is arranged in the threaded passage, the second piercing means 29 is provided with an external thread, and the second piercing means 29 can be enabled to penetrate through the threaded passage and extend into the main body 200 by rotating the second piercing means 29. When the detection device is not in use, the second puncturing mechanism 29 is located at the first position, in which the second puncturing mechanism 29 can contact the chromatography test paper 240 but does not puncture the sealing layer 221 below the chromatography test paper 240, so that the liquid in the liquid storage tank 220 does not react with the sample solution on the chromatography test paper 240 and in the sample tube 100, thereby ensuring that the chromatography test paper 240 can be used smoothly. When the second puncturing mechanism 29 is moved to the second position, i.e., the second puncturing mechanism 29 is continuously rotated, the second puncturing mechanism 29 approaches the sealing layer 221, and can puncture the sealing layer 221, so that the liquid in the liquid storage tank 220 reacts with the sample solution on the chromatographic test paper 240 and in the sample tube 100, thereby preventing the nucleic acid remaining in the detection apparatus from being contaminated due to the internal exposure.

In order to ensure that the second puncturing mechanism 29 does not puncture the sealing layer 221 when the detecting device is not in use, and to ensure the usability of the detecting device, according to another embodiment of the present invention, as shown in fig. 1-3, a baffle 230 is disposed between the sealing layer 221 and the second puncturing mechanism 29, the baffle 230 is movable from a third position to a fourth position, when the baffle 230 is located at the third position, the baffle 230 prevents the second puncturing mechanism from moving downward, and when the baffle 230 is moved to the fourth position, the second puncturing mechanism 29 can puncture the sealing layer 221 as the sample tube 100 is rotated in. By providing the baffle 230, the operator is further prevented from performing an erroneous operation, and the nucleic acid-disrupting reagent is brought into contact with the chromatographic test paper 240 when the detection has not been completed.

According to another embodiment of the present invention, a resilient pressing structure 280 is disposed above the chromatographic test strip 240, and when the baffle 230 is opened, the resilient pressing structure 280 presses at least a portion of the chromatographic test strip 240 into the liquid storage tank 220. The elastic pressing structure 280 is not particularly limited, and may be a spring or a leaf spring.

Further, the specific structure for realizing the sealing of the accommodating chamber 210 may refer to any manner known in the prior art, which is not described herein, for example, the sample solution adding region 260 may be configured to match the sample tube 100 by setting the shape thereof, and after the sample tube 100 is inserted into the sample solution adding region 260, the surfaces of the two are attached to each other, so as to realize the sealing of the accommodating chamber 210. According to another embodiment of the present invention, the sample solution adding region 260 includes a cylindrical first channel (not shown), and in order to effectively prevent the expansion product from leaking into the air, a sealing ring made of an elastomer may be further provided at the insertion end of the first channel, or a sealing ring made of an elastomer may be provided outside the sidewall 110 of the sample tube 100.

According to another embodiment of the present invention, the test result observation area 270 is made of a transparent material for easy observation.

It should be noted that, the specific structure and the manufacturing material of the sample tube are not limited in the present invention, and may be reasonably selected according to actual needs, as long as the sample tube can stably store the sample solution and can be punctured by the first puncturing mechanism.

Specifically, referring to fig. 1-2, in this embodiment, the sample tube 100 includes a side wall 110, a bottom wall 120, and an upper wall 130, and a sealed sample solution storage cavity 140 defined by the side wall 110, the bottom wall 120, and the upper wall 130, wherein the side wall 110 is a cylindrical side wall, and an external thread 150 is provided on an outer surface thereof for cooperating with an internal thread of the first channel to seal the side wall 110 of the sample tube 100 with the first channel.

In accordance with another embodiment of the present invention, in order to facilitate the puncturing of the sample tube 100 by the puncturing mechanism 250 after the sample tube 100 is inserted into the portable test strip testing device, the bottom wall 120 of the sample tube 100 may be provided with a cut mark to facilitate the puncturing of the sample tube 100 by the first puncturing mechanism 250.

Further, since the bottom wall 120 of the sample tube 100 is provided with a cut, the sample tube 100 may be damaged at the cut position during the taking and placing process before being inserted into the portable test strip detection device. Therefore, according to another embodiment of the present invention, the bottom wall 120 of the sample tube 100 is recessed into the sample solution storage cavity 140 to form a recess 121, and only the recess 121 is provided with a cut trace, so that the damage of the sample tube 100 during the taking and placing process can be effectively avoided.

According to another embodiment of the present invention, the sample container 100 is generally of an open-lid structure, i.e., the upper wall 130 is an openable lid, and the sample to be amplified and the reagents related to the amplification reaction system are placed in the sample container 100, and then the lid is closed to achieve sealing. In addition, the upper portion of the syringe 100 may also be directly formed as a closed structure, i.e., the upper wall 130 and the sidewall 110 are fixedly connected, or even directly formed integrally, and cannot be opened. When in use, the injector with the fine needle penetrates through the upper wall 130 of the sample tube 100, the reaction system is injected, and then the opening is sealed by a sealing film or a wax drop with a higher melting point, so that the sample tube 100 can be better sealed.

Further, some poor or laggard areas have been heavily stricken by infectious diseases due to poor quality, poor hygiene, low hygiene awareness, malnutrition, etc. The infectious diseases have high incidence and death rate, and the high treatment cost is difficult to be borne by the ordinary families. However, in these areas, advanced infectious disease detection methods are not widespread, mainly because of the difficulty in supplying power in most areas and the inability to operate large instruments; the cost of large-scale medical equipment and the corresponding cost of maintenance equipment cannot be borne; site restriction; the patient cannot afford the high examination cost, etc. While the amplification reaction in the sample tube 100 needs to be performed in a specific temperature range, it may be difficult for the detection personnel to obtain a temperature constant device in the above-mentioned region, and the detection cannot be performed on the spot, which limits the instantaneity of the nucleic acid detection.

According to another embodiment of the present invention, the surface of the sample tube 100 is coated with at least two reversible temperature-sensitive color-changing materials. The color-changing temperature of the temperature-sensitive color-changing material can be set according to the actual situation, and the specific reversible temperature-sensitive color-changing material can be a commercially available product. For a certain amplification reaction, if the reaction temperature is required to be between a first temperature T1 and a second temperature T2, two temperature-sensitive color-changing materials can be selectively coated on the surface of the sample tube 100, wherein the color-changing temperature of the first temperature-sensitive color-changing material is the first temperature T1, and the color-changing temperature of the second temperature-sensitive color-changing material is the second temperature T2. Thus, when the first temperature sensitive material changes color and the second temperature sensitive material does not change color during the amplification reaction, it indicates that the temperature is suitable for the amplification reaction in the sample tube 100. In this way, the sample tube 100 can be directly placed in a thermos bottle, and the temperature of water in the thermos bottle can be controlled by adjusting the amount of cold water and hot water, so that the amplification reaction can be maintained, and the sample can be detected at any time and any place without using a thermostatic device.

For example, if the optimal reaction temperature is about 38 ℃, the temperature-sensitive paint can be selected from 2 temperatures, which are respectively greater than 38 and less than 38, preferably 37 and 39 ℃, if the optimal reaction temperature is 63 ℃, the temperature-sensitive paint can be selected from 62 and 64, the shape of the temperature-sensitive paint can be any, but preferably arabic numerals corresponding to the temperature, such as 38-degree discolored temperature-sensitive material, shown as "38". This may more directly reflect the temperature of the sample tube 100.

Further, if the sample tube 100 is used in amplification reaction systems with different temperatures, a plurality of temperature-sensitive color-changing materials can be arranged.

According to another embodiment of the present invention, the sample tube 100 of the present invention is a specially-made nucleic acid amplification tube, and the sidewall 110 of the sample tube 100 may be made of a series of materials, preferably materials with good thermal conductivity, high strength and good fluidity, such as metal, alloy, thermal conductive plastic and organic composite material, with a height of 1-3cm, preferably 2cm, and a general shape similar to that of a common nucleic acid amplification tube, but with some differences.

While the invention has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that the foregoing is a more detailed description of the invention, taken in conjunction with the specific embodiments thereof, and that no limitation of the invention is intended thereby. Various changes in form and detail, including simple deductions or substitutions, may be made by those skilled in the art without departing from the spirit and scope of the invention.

Claims

1. A portable test paper detection device is characterized by comprising a main body and a sample tube,

a containing cavity is arranged in the main body, a liquid storage tank, a sealing layer, chromatography test paper and a first puncturing mechanism are sequentially arranged in the containing cavity from bottom to top, the upper surface of the liquid storage tank is sealed by the sealing layer, the first puncturing mechanism is fixedly connected in the main body, a fluid channel is arranged on the first puncturing mechanism,

the wall of the main body is further provided with a second puncturing mechanism, one end of the second puncturing mechanism is arranged in the main body, the other end of the second puncturing mechanism is arranged outside the main body, the second puncturing mechanism can move from a first position to a second position, when the detection device is not used, the second puncturing mechanism is located at the first position, and when the second puncturing mechanism is moved to the second position, the second puncturing mechanism punctures the sealing layer.

2. A portable dipstick testing device according to claim 1 in which the second lancing mechanism is threadably connected to the body and is moveable from the first position to the second position by rotation of the second lancing mechanism.

3. A portable dipstick testing device according to claim 1 in which a barrier is provided between the sealing layer and the second lancing mechanism, the barrier being moveable from a third position to a fourth position, the barrier in the third position blocking downward movement of the second lancing mechanism, the second lancing mechanism being operable to lance the sealing layer as the sample tube is rotated into the fourth position when the barrier is moved to the fourth position.

4. A portable test strip testing device according to claim 3, wherein a sample solution adding region is provided on the upper surface of the main body, the sample solution adding region includes a cylindrical first channel, and a sealing ring made of an elastic body is provided at an insertion end of the first channel, or a sealing ring made of an elastic body is provided outside a sidewall of the sample tube.

5. The portable dipstick testing device of claim 1, wherein the test result observation zone is made of a transparent material.